email   Email Us: phone   Call Us: +1 (914) 407-6109   57 West 57th Street, 3rd floor, New York - NY 10019, USA

Lupine Publishers Group

Lupine Publishers

  Submit Manuscript

ISSN: 2644-1217

Open Access Journal of Complementary & Alternative Medicine

Research ArticleOpen Access

MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo- Controlled Trial Volume 2 - Issue 5

Hossein Pakdaman, Ali Amini Harandi*, Akram Esfandani, Atefeh Yousefi, Marziyeh Khazai Pol, Behnam Mansouri, Ali Sobhanian and Sina Asadi

  • Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Received:October 05, 2020;   Published:October 12, 2020

*Corresponding author: Ali Amini Harandi, Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, South Kargar Street, Tehran, Iran

FullText PDF

To view the Full Article   Peer-reviewed Article PDF


Background: Despite recent developments in intensive care for patients with Traumatic brain injury (TBI), the long-term neurological disabilities still exist. MLC901 is Traditional Chinese Medicine and has shown some neuroprotective and neuro regenerative benefits after brain injury in previous animal and human studies and may provide a new therapeutic approach in the treatment of TBI. Accordingly, we conducted this pilot, randomized, double-masked, placebo-controlled study to investigate the efficacy of MLC901 in patients with moderate to severe TBI.

Materials and Methods: Patients with a diagnosis of moderate to severe TBI were enrolled. Subjects were randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months. Evaluation of patients was carried out at baseline, 3rd month and 6th month follow-after injury. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) were used to examine patients. Efficacy was evaluated by comparing these two scores between the 2 groups at follow-up visits.

Results: Eighty-one patients complete 6 months follow up. There was no significant difference between two study groups regarding the demographic features, interval between injury and start of intervention and length of ICU stay. However, functional outcome scales of GOS, MRS at 3rd and 6th month post-injury were significantly better in MLC901 group compared to placebo (p<0.05).

Conclusion: MLC901 has shown promising efficacy in patients suffering from moderate to severe TBI.

Keywords: NeuroAid, MLC901; Traumatic brain injury; Placebo-controlled study, Modified rankin scale, Glasgow outcome scale, Functional outcome

Abstract| Introduction| Materials and Methods| Results| Discussion| Conclusion| Acknowledgments | Conflict of Interest| References|